REGENERON PHARMACEUTICALS, INC.

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•changes in laws, regulations, and policies affecting the healthcare industry;

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•other changes in laws, regulations, and policies affecting the healthcare industry;

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(h) Information in this column captures submissions to U.S., EU, and Japan regulatory authorities

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(h) Information in this column captures submissions to U.S., EU, and/or Japan regulatory authorities

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(l) Under the terms of our license agreement for cemdisiran, Alnylam is entitled to receive royalties on sales (if any), as well as sales milestones

Current wording

(l) Under the terms of our license agreement for cemdisiran, Alnylam is entitled to receive royalties on sales (if any), as well as milestone payments

Previous wording

In May 2025, the Company and Sanofi announced that a Phase 3 trial, AERIFY-1, in adults who were former smokers with inadequately controlled COPD met the primary endpoint of significantly reducing moderate or severe acute exacerbations by 27% compared to placebo at week 52, a clinically meaningful benefit. A second Phase 3 trial, AERIFY-2, did not meet the same primary endpoint, although a benefit was seen earlier in the trial. The safety profile of itepekimab observed in the Phase 3 trials was consistent with prior clinical trials. The Company and Sanofi are reviewing the data and will discuss with regulatory authorities to evaluate next steps.

Current wording

In May 2025, the Company and Sanofi announced that a Phase 3 trial, AERIFY-1, in adults who were former smokers with inadequately controlled COPD met the primary endpoint of significantly reducing moderate or severe acute exacerbations by 27% compared to placebo at week 52, a clinically meaningful benefit. A second Phase 3 trial, AERIFY-2, did not meet the same primary endpoint, although a benefit was seen earlier in the trial. The safety profile of itepekimab observed in the Phase 3 trials was consistent with prior clinical trials. The Company and Sanofi are evaluating next steps.

Previous wording

In April 2025, a pre-planned interim analysis was conducted on two ongoing Phase 2/3 studies evaluating the combination of fianlimab and cemiplimab in first-line advanced NSCLC. Due to limited follow-up, the Phase 2 portion of the studies will continue unchanged until additional data are available. The next analyses for these studies are expected in the first quarter of 2026, at which time a decision whether to advance to Phase 3 is expected to be made. No new safety signals were observed in either study.

Current wording

In April 2025, a pre-planned interim analysis was conducted on two ongoing Phase 2/3 studies evaluating the combination of fianlimab and cemiplimab in first-line advanced NSCLC. Due to limited follow-up, the Phase 2 portion of the studies will continue unchanged until additional data are available. The next analyses for these studies are expected in the first half of 2026, at which time a decision whether to advance to Phase 3 is expected to be made. No new safety signals were observed in either study.

Previous wording

We are collaborating with Sanofi on the global development and commercialization of Dupixent, Kevzara, and itepekimab (the "Antibody Collaboration"). Under the terms of the Antibody Collaboration, Sanofi is generally responsible for funding 80% to 100% of agreed-upon development costs. We are obligated to reimburse Sanofi for 30% to 50% of development expenses that were funded by Sanofi based on our share of collaboration profits; however, we are only required to apply 20% of our share of profits from the collaboration each calendar quarter to reimburse Sanofi for these development expenses. As of June 30, 2025, the total amount of our contingent reimbursement obligation to Sanofi (i.e., "development balance") in connection with such development expenses was approximately $1.2 billion.

Current wording

We are collaborating with Sanofi on the global development and commercialization of Dupixent, Kevzara, and itepekimab (the "Antibody Collaboration"). Under the terms of the Antibody Collaboration, Sanofi is generally responsible for funding 80% to 100% of agreed-upon development costs. We are obligated to reimburse Sanofi for 30% to 50% of development expenses that were funded by Sanofi based on our share of collaboration profits; however, we are only required to apply 20% of our share of profits from the collaboration each calendar quarter to reimburse Sanofi for these development expenses. As of September 30, 2025, the total amount of our contingent reimbursement obligation to Sanofi (i.e., "development balance") in connection with such development expenses was approximately $905 million.

Previous wording

In July 2025, our license agreement with Hansoh Pharmaceuticals Group Company Limited to acquire development and commercial rights outside of mainland China, Hong Kong, and Macau for HS-20094 (a dual GLP-1/GIP receptor agonist currently in Phase 3 clinical development in China) became effective. In-licensing a late-stage GLP1/GIP agonist enables us to study combinations with our products and product candidates in order to address muscle loss and potentially other comorbidities of obesity, such as cardiovascular diseases, diabetes, and liver conditions. Under the terms of the agreement, we made an $80.0 million up-front payment in July 2025. In addition, we are obligated to make additional payments upon achievement of development, regulatory, and sales milestones, as well as a low double-digit royalty on sales.

Current wording

In July 2025, our license agreement with Hansoh Pharmaceuticals Group Company Limited to acquire development and commercial rights outside of mainland China, Hong Kong, and Macau for HS-20094 (a dual GLP-1/GIP receptor agonist currently in Phase 3 clinical development in China) became effective. In-licensing a late-stage GLP-1/GIP agonist enables us to study combinations with our products and product candidates in order to address muscle loss and potentially other comorbidities of obesity, such as cardiovascular diseases, diabetes, and liver conditions. Under the terms of the agreement, we made an $80.0 million up-front payment in July 2025. In addition, we are obligated to make additional payments upon achievement of development, regulatory, and sales milestones, as well as a low double-digit royalty on sales.

Previous wording

Our ability to generate profits and to generate positive cash flow from operations over the next several years depends significantly on the success in commercializing EYLEA HD, EYLEA, and Dupixent. We expect to continue to incur substantial expenses related to our research and development activities, and our research and development activities and related costs which are not reimbursed by collaborators are expected to expand and require additional resources. We also expect to incur substantial costs related to the commercialization of our marketed products. Our financial results may fluctuate from quarter to quarter and will depend on, among other factors, the net sales of our products; the scope and progress of our research and development efforts; the timing of certain expenses; the continuation of our collaborations, in particular with Sanofi and Bayer, including our share of collaboration profits from sales of commercialized products and the amount of reimbursement of our research and development expenses that we receive from collaborators; and the amount of income tax expense we incur, which is partly dependent on the profits or losses we earn in each of the countries in which we operate. There is uncertainty surrounding whether or when new products or new indications for marketed products will receive regulatory approval or, if any such approval is received, whether we will be able to successfully commercialize such products and whether or when they may become profitable.

Current wording

Our ability to generate profits and to generate positive cash flow from operations over the next several years depends significantly on the success in commercializing our products, including EYLEA HD and Dupixent. We expect to continue to incur substantial expenses related to our research and development activities, and our research and development activities and related costs which are not reimbursed by collaborators are expected to expand and require additional resources. We also expect to incur substantial costs related to the commercialization of our marketed products. Our financial results may fluctuate from quarter to quarter and will depend on, among other factors, the net sales of our products; the scope and progress of our research and development efforts; the timing of certain expenses; the continuation of our collaborations, in particular with Sanofi and Bayer, including our share of collaboration profits from sales of commercialized products and the amount of reimbursement of our research and development expenses that we receive from collaborators; and the amount of income tax expense we incur, which is partly dependent on the profits or losses we earn in each of the countries in which we operate. There is uncertainty surrounding whether or when new products or new indications for marketed products will receive regulatory approval or, if any such approval is received, whether we will be able to successfully commercialize such products and whether or when they may become profitable.

Previous wording

Net product sales of EYLEA HD increased for the three and six months ended June 30, 2025, compared to the same periods in 2024, due to higher sales volumes.

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Net product sales of EYLEA HD increased for the three and nine months ended September 30, 2025, compared to the same periods in 2024, due to higher sales volumes, partly offset by a lower net selling price.

Previous wording

Net product sales of EYLEA for the three and six months ended June 30, 2025, compared to the same periods in 2024, were negatively impacted by (i) lower sales volumes as a result of continued competitive pressures (as described below), loss in market share to compounded bevacizumab due to patient affordability constraints, and the continued transition of patients to EYLEA HD, and (ii) a lower net selling price.

Current wording

Net product sales of EYLEA for the three and nine months ended September 30, 2025, compared to the same periods in 2024, were negatively impacted by (i) lower sales volumes as a result of continued competitive pressures (as described below), loss in market share to compounded bevacizumab due to patient affordability constraints, and the continued transition of patients to EYLEA HD, and (ii) a lower net selling price.

Previous wording

The increase in our share of profits for the three and six months ended June 30, 2025, compared to the same periods in 2024, was driven by higher profits associated with Dupixent sales.

Current wording

The increase in our share of profits for the three and nine months ended September 30, 2025, compared to the same periods in 2024, was driven by higher profits associated with an increase in Dupixent sales.

Previous wording

Bayer records net product sales of EYLEA 8 mg and EYLEA outside the United States. Regeneron's share of profits in connection with commercialization of EYLEA 8 mg and EYLEA outside the United States is summarized below:

Current wording

Regeneron's share of profits in connection with commercialization of EYLEA 8 mg and EYLEA outside the United States is summarized below:

Previous wording

Other revenue increased for the three and six months ended June 30, 2025, compared to the same periods in 2024. Other revenue included royalties and share of profits earned in connection with license agreements of $117.8 million and $69.4 million for the three months ended June 30, 2025 and 2024, respectively, and $187.6 million and $116.9 million for the six months ended June 30, 2025 and 2024, respectively.

Current wording

Other revenue increased for the three and nine months ended September 30, 2025, compared to the same periods in 2024. Other revenue included royalties and share of profits earned in connection with license agreements of $165.4 million and $90.7 million for the three months ended September 30, 2025 and 2024, respectively, and $353.0 million and $207.5 million for the nine months ended September 30, 2025 and 2024, respectively.

Previous wording

Selling, general, and administrative expenses decreased for the three and six months ended June 30, 2025, compared to the same periods in 2024, primarily due to lower charitable contributions to an independent not-for-profit patient assistance organization. Selling, general, and administrative expenses included stock-based compensation expense of $91.8 million and $82.6 million for the three months ended June 30, 2025 and 2024, respectively, and $187.0 million and $168.8 million for the six months ended June 30, 2025 and 2024, respectively.

Current wording

Selling, general, and administrative expenses decreased for the three and nine months ended September 30, 2025, compared to the same periods in 2024, primarily due to lower charitable contributions to an independent not-for-profit patient assistance organization. Selling, general, and administrative expenses included stock-based compensation expense of $92.0 million and $83.1 million for the three months ended September 30, 2025 and 2024, respectively, and $279.0 million and $251.9 million for the nine months ended September 30, 2025 and 2024, respectively.

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Gross margin on net product sales decreased for the three and six months ended June 30, 2025, compared to the same periods in 2024, partly due to ongoing investments to support our manufacturing operations and higher inventory write-offs and reserves.

Current wording

Gross margin on net product sales decreased for the three and nine months ended September 30, 2025, compared to the same periods in 2024, partly due to ongoing investments to support our manufacturing operations. In addition, gross margin on net product sales decreased due to higher amortization expense associated with our Libtayo intangible asset as each quarter we record additions to the intangible asset related to royalties due to Sanofi.

Previous wording

Other operating expense (income), net, for the three and six months ended June 30, 2024 reflected a charge of $14.6 million and $29.9 million, respectively, related to the increase in the estimated fair value of the contingent consideration liability recognized in connection with our 2023 acquisition of Decibel Therapeutics, Inc.

Current wording

Other operating (income) expense, net, for the nine months ended September 30, 2024 reflected a charge of $37.9 million related to the increase in the estimated fair value of the contingent consideration liability recognized in connection with our 2023 acquisition of Decibel Therapeutics, Inc.

Previous wording

On July 4, 2025, bill H.R. 1, commonly referred to as the "One Big Beautiful Bill Act" or "OBBBA", was signed into law. The OBBBA significantly revises U.S. corporate income tax laws by, among other things, restoring the option for immediate expense recognition for U.S.-based research and development expenditures and making permanent the first-year bonus depreciation on qualified property. The OBBBA also modifies U.S. taxation on foreign earnings by, among other things, changing the tax rates for global intangible low-taxed income (now known as Net CFC Tested Income) and foreign-derived intangible income (now known as foreign-derived deduction eligible income), modifying the allocation of expenses in calculating foreign tax credits, as well as changing foreign tax credit limitations. We are in the process of evaluating the impact of the OBBBA on our financial statements.

Current wording

On July 4, 2025, bill H.R. 1, commonly referred to as the "One Big Beautiful Bill Act" or "OBBBA," was signed into law, with certain provisions effective in 2025 and others in 2026. The OBBBA significantly revises U.S. corporate income tax laws by, among other things, restoring the option for immediate expense recognition for U.S.-based research and development expenditures and making permanent the ability to claim first-year bonus depreciation on qualified property. The OBBBA also modifies U.S. taxation on foreign earnings by, among other things, changing the tax rates for global intangible low-taxed income (now known as Net CFC Tested Income) and foreign-derived intangible income (now known as foreign-derived deduction eligible income), modifying the allocation of expenses in calculating foreign tax credits, as well as changing foreign tax credit limitations. As a result of the OBBBA being signed into law, we recognized a charge of $44.5 million in the third quarter of 2025 related to the re-measurement of our U.S. net deferred tax assets.

Previous wording

Our effective tax rate for the three and six months ended June 30, 2025 was positively impacted, compared to the U.S. federal statutory rate, primarily by income earned in foreign jurisdictions with tax rates lower than the U.S. federal statutory rate, federal tax credits for research activities, and, in the second quarter of 2025, the release of existing uncertain tax positions recognized upon the effective settlement of the IRS audit of our 2017 and 2018 federal income tax returns. The release of liabilities for uncertain tax positions reduced our effective tax rate for the three and six months ended June 30, 2025 by 3.9% and 2.4%, respectively.

Current wording

Our effective tax rate for the three and nine months ended September 30, 2025 was positively impacted, compared to the U.S. federal statutory rate, primarily by income earned in foreign jurisdictions with tax rates lower than the U.S. federal statutory rate and federal tax credits for research activities, partially offset by the impact of the OBBBA being signed into law. In addition, our effective tax rate for the nine months ended September 30, 2025 was positively impacted by the release of liabilities for uncertain tax positions recognized upon the effective settlement of the IRS audit of our 2017 and 2018 federal income tax returns in the second quarter of 2025, which reduced our effective tax rate for the nine months ended September 30, 2025 by 1.4%.

Previous wording

The change in our effective tax rate for the three and six months ended June 30, 2025, compared to the same periods in 2024, was primarily impacted by the net change in uncertain tax positions, as well as lower tax benefits from less stock option exercises.

Current wording

The increase in our effective tax rate for the three and nine months ended September 30, 2025, compared to the same periods in 2024, was primarily impacted by the net change in uncertain tax positions, as well as lower tax benefits from less stock option exercises and the enactment of the OBBBA.

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Sources and Uses of Cash for the Six Months Ended June 30, 2025 and 2024

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Sources and Uses of Cash for the Nine Months Ended September 30, 2025 and 2024

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Capital expenditures for the six months ended June 30, 2025 included costs incurred in connection with the expansion of our research, preclinical manufacturing, and support facilities at our Tarrytown, New York corporate headquarters. We expect to incur capital expenditures of $880 million to $950 million for the full year of 2025, including in connection with the continued expansion of our facilities in Tarrytown, New York.

Current wording

Capital expenditures for the nine months ended September 30, 2025 included costs incurred in connection with the expansion of our research, preclinical manufacturing, and support facilities at our Tarrytown, New York corporate headquarters. We expect to incur capital expenditures of $850 million to $890 million for the full year of 2025.

Previous wording

Payments for intangible assets for the six months ended June 30, 2025 included $155.0 million related to our purchase of an FDA Rare Pediatric Disease Priority Review Voucher from a third party in the second quarter of 2025.

Current wording

Payments for intangible assets for the nine months ended September 30, 2025 included $155.0 million related to our purchase of an FDA Rare Pediatric Disease Priority Review Voucher from a third party in the second quarter of 2025.

Previous wording

In each of April 2024 and February 2025, our board of directors authorized an additional share repurchase program for up to $3.0 billion of our Common Stock (up to $6.0 billion in the aggregate). The programs have no time limit and can be discontinued at any time. As of June 30, 2025, $2.814 billion remained available for share repurchases under the programs.

Current wording

In each of April 2024 and February 2025, our board of directors authorized an additional share repurchase program for up to $3.0 billion of our Common Stock (up to $6.0 billion in the aggregate). The programs have no time limit and can be discontinued at any time. As of September 30, 2025, $2.156 billion remained available for share repurchases under the programs.

Previous wording

In each of the first and second quarters of 2025, our board of directors declared quarterly cash dividends of $0.88 per share on our Common Stock and Class A Stock. Each quarterly dividend was paid to our shareholders in the quarter in which the dividend was declared.

Current wording

In each of the first, second, and third quarters of 2025, our board of directors declared quarterly cash dividends of $0.88 per share on our Common Stock and Class A Stock. Each quarterly dividend was paid to our shareholders in the quarter in which the dividend was declared.

Previous wording

A summary of critical accounting estimates is presented in Part II, Item 7. "Management's Discussion and Analysis of Financial Condition and Results of Operations" of our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 (filed February 5, 2025). There have been no material changes to critical accounting estimates during the six months ended June 30, 2025.

Current wording

A summary of critical accounting estimates is presented in Part II, Item 7. "Management's Discussion and Analysis of Financial Condition and Results of Operations" of our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 (filed February 5, 2025). There have been no material changes to critical accounting estimates during the nine months ended September 30, 2025.